To Evaluate the Bioavailability of a Tablet of AZD1656

A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
Brief Summary

To evaluate the bioavailability of a tablet of AZD1656.

Overall Status Completed
Start Date December 2008
Completion Date September 2009
Primary Completion Date March 2009
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) Blood samples taken up to 72 hours
Secondary Outcome
Measure Time Frame
Pharmacodynamic variables (Plasma glucose) Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) Taken during treatment periods
Enrollment 11
Condition
Intervention

Intervention Type: Drug

Intervention Name: AZD1656

Description: Single dose oral tablet

Intervention Type: Drug

Intervention Name: AZD1656

Description: Single dose oral suspension

Eligibility

Criteria:

Inclusion Criteria:

- Male or female, type I diabetes patients, female with non child-bearing potential.

- Treated with insulin for more than 3 years. Well controlled HbA1c.

- Have a body mass index (BMI) ≥19 and ≤35

Exclusion Criteria:

- Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product

- Daily use of nicotine containing substances.

Gender: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Research site
Location Countries

United States

Verification Date

November 2009

Responsible Party

Name Title: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products

Organization: AstraZeneca Pharmaceuticals

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Active Comparator

Description: AZD1656 tablet + food

Label: 2

Type: Active Comparator

Description: AZD1656 susp. without food

Label: 3

Type: Active Comparator

Description: AZD1656 tablet

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov